Acronym

STAR

Study hypothesis

Current study hypothesis as of 15/05/2013:The aim of the STAR trial is to evaluate the use of a modified sunitinib or pazopanib schedule compared to the standard sunitinib or pazopanib schedule, in patients with locally advanced and/or metastatic renal cancer. The trial aims to determine whether a modified sunitinib or pazopanib schedule involving a drug-free interval is non-inferior in terms of 2 year overall survival (OS) and quality adjusted life year (QALY) (averaged over trial recruitment and follow-up) compared to sunitinib or pazopanib given according to the standard strategy.

Previous study hypothesis until 15/05/2013:The aim of the STAR trial is to evaluate the use of a modified sunitinib schedule compared to the standard sunitinib schedule, in patients with locally advanced and/or metastatic renal cancer. The trial aims to determine whether a modified sunitinib schedule involving a drug-free interval is non-inferior in terms of 2 year overall survival (OS) and quality adjusted life year (QALY) (averaged over trial recruitment and follow-up) compared to a sunitinib given according to the standard strategy.

On 15/05/2013 the following changes were made to the trial record:1. The public title was previously "Standard vs Modified Sunitinib Treatment in Renal Cancer"2. The scientific title was previously "A randomised multi stage, phase II/III trial of sunitinib. Comparing temporary cessation with allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced and/or metastatic renal cancer"

Study design

Primary study design

Secondary study design

Trial setting

Trial type

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Locally advanced and/or metastatic clear cell renal cancer

Intervention

Current interventions as of 31/10/2014:Sunitinib: one cycle of treatment refers to 50mg (starting dose) od, days 1-28, repeated every 42 days. Pazopanib: one cycle of treatment refers to 800mg (starting dose) od, days 1-42, repeated every 42 days.

All patients receive sunitinib or pazopanib and will be randomised to receive either drug according to either a Conventional continuation strategy (CCS) or drug-free interval strategy (DFIS)

Research arm: Disease-free interval strategy (DFIS) Patients stop treatment after 4 cycles of treatment (i.e. 6 months) and continue 6 weekly active surveillance (clinical assessment) and 12 weekly radiological assessment, with planned recommencement of sunitinib or pazopanib at the time of progressive disease (PD) (RECIST). Assuming further disease control, sunitinib or pazopanib is then continued again for a minimum of 4 cycles. At this point, assuming ongoing disease control, sunitinib or pazopanib can be again temporarily stopped at the discretion of the treating clinician until evidence of PD (RECIST) when again sunitinib or pazopanib is restarted. This DFIS is continued until PD occurs during sunitinib or paozpanib treatment, cumulative toxicity or patient decision to stop treatment or withdraw from the study.

Interventions from 15/05/2013 to 31/10/2014:Sunitinib: one cycle of treatment refers to 50mg (starting dose) od, days 1-28, repeated every 42 days. Pazopanib: one cycle of treatment refers to 800mg (starting dose) od, days 1-42, repeated every 42 days.

All patients receive sunitinib or pazopanib and will be randomised to receive either drug according to either a Conventional continuation strategy (CCS) or drug-free interval strategy (DFIS)

Research arm: Disease-free interval strategy (DFIS) Patients stop treatment and continue 6 weekly active surveillance (clinical assessment) and 12 weekly radiological assessment, with planned recommencement of sunitinib or pazopanib at the time of progressive disease (PD) (RECIST). Assuming further disease control, sunitinib or pazopanib is then continued again until the time of maximal radiological response and for a minimum of 4 cycles. At this point, assuming ongoing disease control, sunitinib or pazopanib can be again temporarily stopped until evidence of PD (RECIST) when again sunitinib or pazopanib is restarted. This DFIS is continued until PD occurs during sunitinib or paozpanib treatment, cumulative toxicity or patient decision to stop treatment or withdraw from the study.

Interventions from time of registration until 15/05/2013:Sunitinib: one cycle of treatment refers to 50mg (starting dose) od, days 1-28, repeated every 42 days.

All patients receive sunitinib and will be randomised to receive it according to either a Conventional continuation strategy (CCS) or drug-free interval strategy (DFIS)

Research arm: Disease-free interval strategy (DFIS)Patients stop treatment and continue 6 weekly active surveillance (clinical assessment) and 12 weekly radiological assessment, with planned recommencement of sunitinib at the time of progressive disease (PD) (RECIST). Assuming further disease control, sunitinib is then continued again until the time of maximal radiological response and for a minimum of 4 cycles. At this point, assuming ongoing disease control, sunitinib can be again temporarily stopped until evidence of PD (RECIST) when again sunitinib is restarted. This DFIS is continued until PD occurs during sunitinib treatment, cumulative toxicity or patient decision to stop treatment or withdraw from the study.

Participant type

Age group

Gender

Target number of participants

Participant exclusion criteria

Current exclusion criteria as of 31/10/2014:1. Pulmonary or mediastinal disease causing obstruction or clinically significant bleeding/haemoptysis 2. Patients with an estimated life expectancy of <6 months 3. Known contraindications to the particular TKI to be used (i.e. sunitinib or pazopanib)4. Any previous treatment with sunitinib, pazopanib or other tyrosine kinase inhibitor (including in the adjuvant setting) 5. Untreated brain metastases 6. Any concurrent or previous other invasive cancer that could confuse diagnosis or endpoints6.1. Allowed situations include (but not limited to): non-melanomatous skin cancer or superficial bladder cancer; for all other cases please discuss with Clinical Trials Research Unit (CTRU)) 7. Hypersensitivity to the particular TKI to be used (i.e. sunitinib or pazopanib) 8. Any concomitant medication or substances forming part of local ongoing care known to significantly affect, or have the potential to significantly affect, the activity or pharmacokinetics of the particular TKI to be used (i.e. sunitinib or pazopanib) 9. Poorly controlled hypertension despite maximal medical therapy 10. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the STAR trial, including gastro-intestinal abnormalities limiting effectiveness of orally administrated drugs, uncontrolled infections, current or recent history of clinically significant cardiovascular disease, significant haemorrhage or gastrointestinal perforation or fistula which, in the opinion of the local investigator, would render the patient unsuitable for standard sunitinib or pazopanib therapy

Exclusion criteria from 15/05/2013 to 31/10/2014:1. Pulmonary or mediastinal disease causing obstruction or bleeding/haemoptysis 2. Patients with an estimated life expectancy of <6 months 3. Known contraindications to sunitinib or pazopanib4. No previous treatment with sunitinib, pazopanib or other tyrosine kinase inhibitor (including in the adjuvant setting) 5. Untreated brain metastases 6. Any concurrent or previous other invasive cancer that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer acceptable, for all other cases please discuss with Clinical Trials Research Unit (CTRU)) 7. Hypersensitivity to sunitinib or pazopanib8. Any concomitant medication or substances forming part of local ongoing care known to significantly affect, or have the potential to significantly affect, the activity or pharmacokinetics of sunitinib or pazopanib (see section 10.2 for further information on concomitant medications) 9. Poorly controlled hypertension despite maximal medical therapy 10. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the STAR trial, including gastro-intestinal abnormalities limiting effectiveness of orally administrated drugs, uncontrolled infections, current or recent history of clinically significant cardiovascular disease, significant haemorrhage or gastrointestinal perforation or fistula which, in the opinion of the local investigator, would render the patient unsuitable for standard sunitinib or pazopanib therapy

Exclusion criteria from time of registration until 15/05/2013:1. Pulmonary or mediastinal disease causing obstruction or bleeding/haemoptysis 2. Patients with an estimated life expectancy of <6 months3. Known contraindications to sunitinib 4. No previous treatment with sunitinib or other tyrosine kinase inhibitor (including in the adjuvant setting)5. Untreated brain metastases 6. Any concurrent or previous other invasive cancer that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer acceptable, for all other cases please discuss with Clinical Trials Research Unit (CTRU))7. Hypersensitivity to sunitinib8. Any concomitant medication or substances forming part of local ongoing care known to significantly affect, or have the potential to significantly affect, the activity or pharmacokinetics of sunitinib (see section 10.2 for further information on concomitant medications) 9. Poorly controlled hypertension despite maximal medical therapy 10. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the STAR trial, including gastro-intestinal abnormalities limiting effectiveness of orally administrated drugs, uncontrolled infections, current or recent history of clinically significant cardiovascular disease which, in the opinion of the local investigator, would render the patient unsuitable for standard sunitinib therapy